The race for pharma to embrace real-world evidence

After attending Adelphi's Renaissance event in Paris, focussed on how real-world evidence is impacting the pharma industry, Paul Tunnah sees comparative challenges between perfection and reality to the world of F1 motorsport.

Formula 1 cars represent the absolute pinnacle of automotive technology. An F1 team can easily spend hundreds of millions of dollars over a racing season, with every component of a race car being honed to perfection, through test after test after test, designed to deliver maximum speed, and safety, in the most efficient manner.

It would therefore be logical to assume that F1 research plays a major role in developing better road cars. So why have several very successful mass automotive manufacturers, such as Porsche and Audi, declared it irrelevant to their business in recent years?

Simple – much of the technology used in F1 just does not work in the real world.

The situation could well be compared to the challenge facing the global pharmaceutical industry. Every year it invests billions in medical research to deliver drugs that, in the clinic, deliver life-changing, or even life-saving, benefit to patients. But, like its F1 cousins, pharma's products often fare less well in the real world.

I was invited to an exploration of the issues behind this during this week's Renaissance meeting in Paris, run by Adelphi, focussed on how real-world evidence is impacting pharma. Without stealing too much thunder from their forthcoming article on the meeting, allow me to explore a few key challenges further with relevance to my F1 analogy.

1. The gap between clinic and reality

F1 cars are designed to race in the 'clinical' setting of a race track. Here, cars can sit just inches above the surface without worrying about the destructive consequences of hitting potholes or speed bumps, rather like clinical trial drugs not worrying about other drug interactions in their carefully controlled environment.

In addition, no passengers are carried in an F1 car, meaning the driver is only concerned with one thing – going fast. In the world of health, patients often have to deal with the medical 'passengers' of comorbidities, which might severely impact medicine effectiveness, or increase side effects.

2. Team support versus isolated patients

The racing drivers fortunate enough to find themselves behind the seat of an F1 car have years of training behind them and are supported by an extended team of experts who are with them every step of the way in practice and race sessions to keep them going. Likewise, the clinical setting patient is carefully selected and regularly monitored to meet stringent safety requirements.

But in the real world, like the learner driver who has just passed their test, patients often lack the medical training and immediate support networks to know how to deal with unexpected side effects. In addition, they may, either intentionally or unintentionally, fail to take their medicine as directed, with clear consequences for their health outcome versus their clinical-setting forerunners. In turn, those holding the healthcare purse strings fail to see the benefit on the disease management frontline and the value of the 'medical innovation' is lost.

"Approaching payers with pivotal phase III evidence designed for regulators is no longer sufficient"

3. The cost of perfection

Even if you could drive an F1 car on your local street, the cost of buying one would be astronomical. On average, the parts alone making up the average race car bring the cost well into Bugatti Veyron territory at over $1.5m, but the true cost is even higher when you take account of the R&D investment and support team.

Likewise, even the most emotive and carefully constructed argument from underserved patients has to face the reality that healthcare spend cannot keep increasing at the current rate. Sadly, innovative new pharmaceutical treatments are of limited use if healthcare systems are not convinced that the incremental benefit they bring to disease management justifies the investment.

Bridging the race track and the road

The good news is that, like Formula 1, the pharmaceutical industry is reacting to the reality of the world it now operates in and is embracing the need for real-world evidence to support the value of its medicines on the motorways of life.

At a high level, three main areas emerged from the meeting as important to help pharma do so:

• Earlier engagement with payers: Approaching payers with pivotal phase III evidence designed for regulators is no longer sufficient. They must be engaged earlier in the development process to ensure evidence endpoints and comparators provide outputs that are useful to decision making in the real world. Payers no more like saying 'no' to a drug which could improve or revolutionise patient outcomes than pharma likes to hear it and they are working more closely with regulators, so why not seek their counsel early?

• More unified datasets / processes: While real-world evidence is becoming an essential component of ongoing market access, the innumerable sources and resource involved in collecting and collating it is in danger of becoming misaligned with managing development costs. For everyone involved in healthcare, from pharma to payers, patients and providers, there is a need for more efficient, unified data collection, integration and analytical processes aligned around clearly defined decision drivers.

• Better pharma education around real-world evidence: Whether pharma companies believe in separate real-world evidence teams or up skilling current roles around this area, there is no escaping the fact that real-world evidence impacts on many roles across the drug lifecycle, from early clinical development to late-stage commercial management. Why invest billions in clinical research without appropriate investment in a capability to evidence real-world outcomes?

Even within the controlled settings of a race track, history has shown that an F1 team that fails to deliver winning cars is destined for a short existence, no matter how much investment backing it has.

"Why invest billions in clinical research without appropriate investment in a capability to evidence real-world outcomes?"

The pharmaceutical industry has to face up to a similar reality. The billions spent on researching new medicines have to translate to a 'win' for healthcare systems and patients in the real world. The ability to harness real-world evidence at every stage of their business will be the key determinant between those pharmaceutical companies that succeed and those who unwittingly drive off into the sunset.

pharmaphorum wishes to acknowledge Adelphi for the invitation to attend Renaissance. For more information about this, and earlier meetings, please go to:

http://www.adelphigroup.com/index.php/renaissance_series

About the author:

Paul Tunnah is CEO & Founder of pharmaphorum media, which provides digital content marketing and communications solutions for the pharma sector and also manages the industry leading channel www.pharmaphorum.com, a digital podium for communicating thought leadership and innovation within pharma. For queries he can be reached through the site contact form or on Twitter @pharmaphorum.

To contact Adelphi, please visit:

http://www.adelphigroup.com/index.php/contact

Closing thought: How does pharma deliver medicines that work in the real world?